Phase 2b dose-ranging study of ALX-0171 in infants and young children hospitalized for RSV lower respiratory tract infection

• Register: EUCTR
• Last refreshed on: 25 June 2018
• Main ID: EUCTR2016-001651-49-EE
• Date of registration: 30/08/2016
• Prospective Registration: Yes
• Primary sponsor: Ablynx NV
• Public title: Phase 2b dose-ranging study of ALX-0171 in infants and young children hospitalized for RSV lower respiratory tract infection
• Scientific title: A randomized, double-blind, placebo-controlled, multicenter dose ranging study of ALX-0171 in infants and young children hospitalized for respiratory syncytial virus lower respiratory tract infection - Respire
• Date of first enrolment: 20/09/2016
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001651-49
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Estonia, Germany, Hungary, Israel, Latvia, Lithuania, Malaysia, Philippines, Poland, Slovakia, South Africa, Spain, Thailand, United Kingdom, United States

Contacts

• Name: [e-mail]
• Affiliation: Ablynx NV

• Name: [e-mail]
• Affiliation: Ablynx NV

Key inclusion & exclusion criteria

Inclusion criteria:
- Subject is a male or female infant or young child aged 28 days to < 2 years with gestational age = 33 weeks.
- Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV lower respiratory tract infection.
- Subject has a positive RSV diagnostic test.
- Subject is expected to have to stay in the hospital for at least 24 hours.
- Parent(s)/legal guardian(s) provide written informed consent in accordance with locally approved consent process.

Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Subject is known to have significant comorbidities
- Subject is known to be HIV-positive (or if the child is <6 months of age, the mother is known to be HIV-positive).
- Subject is known to be immunocompromised.
- Subject has or is suspected to have an active, clinically relevant concurrent infection
- Subject is critically ill and/or is expected to require invasive mechanical ventilation
- Subject is currently participating in any other study with investigational drug or has received an investigational drug within 4 weeks or 5 half-lives of the concerned drug (whichever is longer) prior to screening
- Subject was previously enrolled in a clinical study of ALX-0171



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

RSV lower respiratory tract infection
MedDRA version: 19.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: ALX-0171 Nanobody
Product Code: ALX-0171
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: not assigned yet
CAS Number: not assigned
Current Sponsor code: ALX-0171
Other descriptive name: ALX-0171 Nanobody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: To evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for RSV lower respiratory tract infection.

Timepoint(s) of evaluation of this end point: Throughout the in-hospital period, up to Day 14 after randomization

Primary end point(s): Anti-viral effect, as measured by the time needed for the viral load to drop below the assay quantification limit.

Secondary Objective: To evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Throughout the study, up to Day 28 after randomization

Secondary end point(s): - Safety assessment (assessed by physical examination, AEs, laboratory assessments and vital signs) of different doses of ALX-0171
- Change from baseline in Global Severity Score
- Time to clinical response
- PK properties of ALX-0171
- Viral load profile over time
- Evaluation of serum anti-drug antibodies (ADA)

Secondary ID(s)

ALX0171-C201

2016-001651-49-GB

Source(s) of Monetary Support

Ablynx NV